Containers for dispensing physiological solutions

ABSTRACT

A container for dispensing a physiological solution comprising a flexible ampul member, a hanger provided on the top end wall of said ampul member, a thin wall portion formed in said top end wall for permitting a syringe needle to pass through, said thin wall portion having a thickness of 0.2 to 0.4 mm., and a tubular projection provided in the bottom end portion of said ampul member.

United States Patent Masahito Otsuka Tokyo-to, Japan Dec. 6, 1968 Mar.16, 1971 Otsuka Pharmaceutical Company Limited Tokyo-to, Japan Apr. 11,1968 Japan Inventor Appl. No. Filed Patented Assignee PriorityCONTAINERS FOR DISPENSING PHYSIOLOGICAL SOLUTIONS 2 Claims, 8 DrawingFigs.

US. Cl. 222/88, 222/88, 215/100 [51] Int. Cl B65d 23/10 PrimaryExaminer-David M. Bockenek Attorney-Larson, Taylor & Hinds ABSTRACT: Acontainer for dispensing a physiological solution comprising a flexibleampoule member, a hanger provided on the top end wall of said ampoulemember, a thin wall portion formed in said top end wall for permitting asyringe needle to pass through, said thin wall portion having athickness of 0.2 to 0.4 mm., and a tubular projection provided in thebottom end portion of said ampoule member.

CGNTAINERS FOR DISPENSING PHYSIOLOGICAL SOLUTIONS This invention relatesto a container for the dispensing of physiological solutions,particularly to an improved flexible container for the storage anddispensing of physiological solutions.

In the prior art a glass container was widely used to dispensephysiological solutions, such as isotonic sodium chloride solution,Ringers solution, Lockes solution, glucose solution, blood, etc. Forthis purpose it has been proposed recently to utilize flexiblecontainers made of polyethylene and the like materials havingflexibility and transparency. Such flexible container has an advantageof being free of fragility of glass as compared with the glasscontainer, but in practical use it has such drawbacks as illustratedbelow. In usual medical practice other medicinal solutions, such asvitamines, medicine for liver, cardiac stimulant, hemostatic, etc. areoften added to the physiological solution contained and sealed in theflexible container by injecting the additional medicines through thewall of the container. In such case the needle is occasionally cloggedwith a scrap of the plastic material of the flexible container, makingthe accurate addition of the medicines diflicult, and even when themedicines are satisfactorily added into the container it is inevitablethat such a scrap contaminates the physiological solution, rendering thesolution spoilt.

Further it is a serious problem to provide a suitable fluid outlet fromthe flexible container, because the fluid in the container must be drawnout without any loss while sterile conditions are maintained. This hasnever been satisfactorily achieved.

A main object of the invention is accordingly to provide a flexiblecontainer which permits later addition of other medicines into thecontainer by injecting them through the wall of the container withoutcontamination by the scrap of the material of the container.

A further object of the invention is to provide a suitable outlet meansfrom the flexible container.

The foregoing and other objects and advantages of the invention willbecome more apparent from a consideration of the detailed descriptionwhich follows, taken together with the accompanying drawings. It is tobe understood, however, that the drawings are for the purpose ofillustration and description only, and are not intended as a definitionof the limits of the invention.

FIG. 1 is a side view partly in section of a flexible container of theinvention.

FIG. 2 is a bottom view of the container shown in FIG. 1.

FIG. 3 is a top view of the container shown in FIG. 1.

FIG. 43 is a fragmentary view illustrating a sealing portion of thecontainer.

FIG. 5 is a fragmentary view illustrating a means for drawing out thesolution from the container.

FIG. s is a longitudinal section of a drawing needle.

FIG. 7 is an enlarged view in section of the drawing needle shown inFIG. 6 along the line H.

FIG. 8 is a fragmentary view illustrating an aspetic air-hole means.

Referring to FIGS. I, 2 and 3 a flexible container embodying theprinciples of the invention is shown.

An ampoule member of oval section, indicated at 1, comprises a top endwall 2, bottom end wall 3 and graduated sidewall 4. These walls 2, 3 and4 usually have a thickness ranging from 0.5 to 1.0 mm., preferably 0.7to 1.0 mm. In the top end wall 2 is provided an aperature' 5, over whichis mounted exteriorly of the ampoule member 1 a hollow projection 6having a thin top wall 7 of a thickness ranging from 0.2 to 0.4 mm.,preferably 0.25 to 0.35 mm. Further on the top wall 2 of the ampoulemember is provided a hanger member 8 with an opening 9, which extendstransversely to reinforce the ampoule member I. An aperture 10 isprovided in the bottom end wall 3 over which a tubular extension 11 ismounted exteriorly of the ampoule member 1.

The flexible container of the above construction is made of polyethyleneand the like materials having flexibility, transparancy and a propertyresistant to the heat to be applied externally in sterilizing aphysiological solution. Particularly desirable material is high pressureprocess polyethylene. The container can be easily prepared by theconventional methods, such as blow moulding. According to the blowmoulding, the hollow projection 6 can be formed integrally by providinga cavity in the mold to correspond to the projection 6, and the thin topwall '7 of the projection 6 can be easily formed integrally due togreater elongation of the portion than the other portions. Theprojection 6 can be formed in any desirable shape and size, but atubular projection having a diameter of 2 to 10 mm. is preferable.

The container illustrated above is charged with a physiological solutionthrough the tubular extension 11, and the end of the extension 11 isthereafter sealed airtight by a suitable means. In the invention it ispreferable, as shown in FIG. 41, to close portion by heat sealing with aplastic cover plate 12 having a downward tubular projection 13, so as tokeep the solution in the ampoule member I airtight.

- The solution sealed in the container is sterilized by applying a heatexternally. Usually a temperature of 101 to 1 12 C. is applied.

When it is required in a hospital to add additional medicines such asvitamins, liver medicines, heart stimulant, hemostatic, etc. to thesolution sealed in the ampoule member 1, such medicines are injectedinto the ampoule member I through the thin top wall 7 of the projection6. As the thickness of the wall 7 is in the range of 0.2 to 0.4 mm., noscrap is made by the insertion of the needle irrespective of the type ofthe needle used, thus assuring easy and accurate addition of theadditional medicines to the solution without blockade of the needle andcontamination of the solution by the scrap. Further, such a thickness as0.2 to 0.4 mm. is sufficient to give the mechanical strength requiredfor this kind of the container. These facts were first confirmed as theresults of numerous experiments by the present inventors.

In pratical use the container having been filled with a physiologicalsolution is hung on a suitable hook inserted to the opening 9 of thehanger 8 provided at the top of the ampoule member 1. The solution isdrawn out from the container by means of the drawing needle shown inFIGS. 5, 6 and 7. The drawing needle, indicated at 14, has a conic topportion 15 with a sharply pointed end 16, and an inner passageway 17extends from the rear end of the needle 14 to the conic top portion 15,where it is branched to three openings 18. Each opening 18 is perforatedin respective grooves 19 which are carved on the conic top portion 15 ofthe needle 14 and extend longitudinally from the vicinity of the pointedend 16 to the openings 18. Most preferably three openings may be formedin the needle 14 as illustrated in FIG. 8, but the number of theopenings may vary, one, two or more than three. The conic top portion 15is integrally joined with a middle portion 20 which is adapted to snuglyfit the inside diameter of the downward tubular projection 13 of thecover plate 12 sealing the bottom end of the tubular extension 11 of theampoule member I. The middle portion 20 is integrally joined with a rearportion 21 of a larger diameter which will be connected to aconventional drawing tube 31 with a flow meter, flow regulater andinjection syringe (not shown). A flange 22 is provided on the rearportion 21 so as to facilitate the insertion of the drawing needle M.

To draw out the solution from the container, the drawing needle 14previously sterilized is inserted through the tubular projection 13 andthe cover plate 12 previously sterilized into the ampoule member 1 tillthe middle portion 20 becomes firmly engaged with the inner wall of thetubular projection 13 as shown in FIG. 5. The needle M has the sharplypointed end 16 and openings 18 perforated in respective grooves 19 atashort distance from the pointed end, so that no plastic scrap isproduced and the solution in the container is drawn out without theblockade of the openings and the contamination of the solution by thescrap. Further as the middle portion 20 of theneedle I4 is firmly keptin engagement with the inner" wall of the tubular projection 13, thesolution can be drawn out from the container without leakage and with acontinuance of the sterile conditions.

In a preferred embodiment, to assure perfect engagement of the needle 14with the tubular projection 13 and prevention of the leakage of thesolution, annular projections 23 may be provided on the inside surfaceof said projection. Further, by inserting elastrneric plug such asrubber plug in the tubular projection 13 more secure result will beobtained, and when the needle is drawn out after use, the plug willblock the hole made in it due to elasticity thereof and automaticallystop further dripping of the solution from the container.

To prevent the entry of germs in the air through the hole which is madein the later addition of medicines on the thin top wall 7 of the hollowprojection 6, a needle 24 with a holder 25 having a sterilized filter 26can be inserted as shown in FIG. 8, to let the air in through thefilter, which greatly satisfies aseptic requirements in drip injection.

The above method can be applied also when no later addition of medicinesis done and the hole is not made in the thin top wall 7. In this way,the deformation of the container can be prevented when drawing out thesolution in the container. That is, when there is no air hole thepressure in the container will decrease by drawing the contents out,thereby giving deformation of the container as the liquid is drawn out.This is an advantage of the flexible container, but by the deformationno longer permits accurate reading of the contents. On the other hand,by providing the above air-hole means the contents can be drawn outaseptically without deformation of the container.

A hollow 27 provided in hanger 8 is intended for receiving the injectionneedle (not shown) to make the container handy to carry with theinjection needle.

Instead of forming the container in an oval section, it may also beround in section.

We claim:

1. A container for dispensing a physiological solution comprising aflexible ampoule member, a hanger provided on the top end wall of saidampoule member, a thin wall portion formed in said top end wall forpermitting a syringe needle to pass through, said thin wall portionhaving a thickness of 0.2 to 0.4 mm., and a tubular projection providedin the bottom end portion of said ampoule member, said ampoule memberbeing sealed airgight by means of a cover plate having a downwardtubular projection.

2. In combination, a container for dispensing a physiological solutioncomprising a flexible ampoule member, a hanger provided on the top endwall of said ampoule member, a thin wall portion formed in said top endwall for permitting a syringe needle to pass through, said thin wallportion having a thickness of 0.2 to 0.4 mm., a tubular projectionprovided in the bottom end portion of said ampoule member, and a coverplate having a downward tubular projection for sealing said ampoulemember airtight, and a drawing needle comprising a conic top portionhaving a sharply pointed end, a middle portion to be snugly fitted intosaid tubular projection of the cover plate to seal the bottom end of thetubular projection of the ampoule member, a rear portion to be connectedto a drawing tube, and an inner passageway penetrated from said rear endportion to said conic top portion proximate to said pointed end andcommunicated with at least one opening formed in the sidewall of saidconic top portion.

1. A container for dispensing a physiological solution comprising aflexible ampoule member, a hanger provided on the top end wall of saidampoule member, a thin wall portion formed in said top end wall forpermitting a syringe needle to pass through, said thin wall portionhaving a thickness of 0.2 to 0.4 mm., and a tubular projection providedin the bottom end portion of said ampoule member, said ampoule memberbeing sealed airgight by means of a cover plate having a downwardtubular projection.
 2. In combination, a container for dispensing aphysiological solution comprising a flexible ampoule member, a hangerprovided on the top end wall of said ampoule member, a thin wall portionformed in said top end wall for permitting a syringe needle to passthrough, said thin wall portion having a thickness of 0.2 to 0.4 mm., atubular projection provided in the bottom end portion of said ampoulemember, and a cover plate having a downward tubular projection forsealing said ampoule member airtight, and a drawing needle comprising aconic top portion having a sharply pointed end, a middle portion to besnugly fitted into said tubular projection of the cover plate to sealthe bottom end of the tubular projection of the ampoule member, a rearportion to be connected to a drawing tube, and an inner passagewaypenetrated from said rear end portion to said conic top portionproximate to said pointed end and communicated with at least one openingformed in the sidewall of said conic top portion.